An Open-label Controlled Trial: Effectiveness of Balneotherapy in Palmoplantar Psoriasis and Contact Dermatitis.
NCT ID: NCT06458868
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
140 participants
INTERVENTIONAL
2014-06-01
2023-10-01
Brief Summary
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The standard protocol for bathing PUVA involved applying 0.01% bath psoralen for 15 minutes, while the tap water group only received a tap water bath for 15 minutes and the salt water group received 3% salted (NaCl) water before UVA treatment.
Main tools to assess the efficacy is disease activity scores and quaity of Life scores.
Detailed Description
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Patients were randomized using a computer program and assessed at the beginning of therapy, as well as after 12, 24, and 36 sessions. The standard bath-PUVA protocol involved applying 0.01% bath psoralen for 15 minutes, while the tap water group only received a tap water bath for 15 minutes, and the salt water group received a 3% salt water bath before UVA exposure.
All patients were educated about their condition and current treatment options. Patients who participated in this study either had contraindications to other therapies or had experienced side effects previously.
The initial UVA dosage was 0.25 J/cm2, gradually increasing to a maximum of 5 J/cm2. During each evaluation, patients were assessed using various scales and tools to measure the severity of their psoriasis and their quality of life, as well as photographs.
Following a pilot study involving 5 patients in each group, a two score reduction in the disease activity score revealed that G power analysis determined that a total of at least 13 patients was needed to achieve 80% power. Ethical approval was obtained before commencing the study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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bath puva
Patients received the standard protocol of bath PUVA with standard psoralen plus tap water in combination with a phototherapy regimen.
No interventions assigned to this group
salt water uva
Patients received saline solution (3% NaCl) in addition to UVA with standard phototherapy regimen.
salt water or tap water before UVA
Instead of using standard bath PUVA, this study investigates the efficacy of tap water or salt water with UVA in the treatment of palmoplantar psoriasis.
tap water uva
Patients received tap water in addition to UVA with standard phototherapy regimen.
salt water or tap water before UVA
Instead of using standard bath PUVA, this study investigates the efficacy of tap water or salt water with UVA in the treatment of palmoplantar psoriasis.
Interventions
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salt water or tap water before UVA
Instead of using standard bath PUVA, this study investigates the efficacy of tap water or salt water with UVA in the treatment of palmoplantar psoriasis.
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of Palmoplantar Psoriasis or Contact Dermatitis
Exclusion Criteria
* Pregnancy or breastfeeding
* History of malignancy
* Diagnosis of photodermatosis
* Prescription or use of photoallergenic or phototoxic drugs
18 Years
65 Years
ALL
No
Sponsors
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Ankara University
OTHER
Responsible Party
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Hilayda Karakok Kısla
Doctor
Principal Investigators
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Nihal Kundakcı, Prof
Role: STUDY_DIRECTOR
Ankara University Faculty of Medicine, Department of Dermatology and Venereology
Locations
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Ankara University School of Medicine
Ankara, , Turkey (Türkiye)
Countries
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Other Identifiers
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BALNEOTERAPİ
Identifier Type: -
Identifier Source: org_study_id